By Christine Moore
For over a decade, FDA has encouraged pharmaceutical manufacturers to use science- and risk-based approaches and to have strong pharmaceutical quality systems for the development and manufacture of drugs. These concepts were laid out in FDA’s 21st Century Initiatives back in 2004, and have further been elaborated on through FDA and international guidance, including ICH Q8(R2), Q9, Q10, and Q11. Experience has shown that a better understanding of the product and process, along with a robust pharmaceutical quality system, including formal risk management tools, can both enhance assurance of product quality and provide financial benefits to firms who utilize them.
While much advancement has been made related to industry’s progress in systematic use of science- and risk-based tools, one area where such a systematic approach has been lacking is within FDA chemistry and manufacturing (CMC) review itself. Traditionally, CMC reviewers have used the information provided by the applicant, literature sources, and their personal expertise and knowledge (and oftentimes the knowledge of their colleagues) to conduct their assessments and to make risk-based decisions. Without systematic tools, however, the analysis of the product and process risks and their mitigations often remain solely within the reviewers’ minds. The details of the risk-based analysis may be lost in translation across quality assessment disciplines (for example, from review to inspection) and from pre- to post-approval.
Introduction of a systematic risk assessment approaches for CMC review is expected to provide benefits, including enhanced knowledge retention of product and process specific risks, better communication of risks between disciplines, and the ability to staff applications more effectively and efficiently. To date, The Center for Drug Evaluation and Research (CDER) has been successful developing a risk assessment tool based on the failure modes, effects, and criticality analysis (FMECA) approach, and is rolling out this tool to be used as part of the assessment of most original new and generic drug applications.
By attending the hot topic session Integration of Risk Assessment in CMC Review on Wednesday, November 5, at the AAPS Annual Meeting and Exposition, you can learn about CDER’s efforts to incorporate a systematic risk assessment approach for both new and generic drugs. We hope to see you there!